Senior Engineer I, Drug Product Process Engineer

Responsibilities

• Maintain the Fill Finish line and provide engineering services, troubleshooting, and technical direction for drug product manufacturing
• Support technology transfer and qualification studies for processes, systems, and facilities
• Partner with Operations, Quality, and Automation on validation studies (IQ/OQ/PQ), cleaning (CIP/COP), and sterilization (SIP/autoclave/VHP)
• Develop and review technical documentation and lead controls fault analysis and remediation
• Provide direct operational support for troubleshooting and issue resolution
• Work on cross-functional teams to support small projects and initiatives within an industrial manufacturing environment

Requirements

• BS or higher in engineering or a related discipline
• Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, or project management
• At least 3 years of project management experience in biologics or GMP environments
• Minimum 5 years of GMP pharmaceutical operations support
• Hands-on experience with Lyophilizers, isolators, and aseptic/sterile filling machines
• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook)
• Experience with project management or design tools such as AutoCAD, Smartsheet, or Microsoft Project
• Strong analytical problem-solving skills and the ability to manage multiple complex priorities

Preferred Qualifications

• Experience with OE and/or LEAN Methodologies
• Experience with production support equipment such as parts washers and autoclaves
• Familiarity with data management and visualization tools like SharePoint, Teams, or Power BI
• Experience working within document management systems such as Veeva Vault or eQMS

Benefits

• Comprehensive medical, dental, and vision insurance
• 401(k) retirement plan
• FSA/HSA options
• Life insurance
• Paid Time Off and Wellness programs
• Eligibility for discretionary equity awards and Employee Stock Purchase Plan

About the Company

BeOne is a global oncology company dedicated to discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a global team of over 11,000 colleagues, BeOne is committed to improving medicine access through a diverse pipeline of novel therapeutics and a culture driven by excellence and collaborative spirit.